ClotTriever
by Inari Medical, Inc. 2 variants
Ref 50-101
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number085029100750-101YZ 00850291007109 | Date6 Apr 2023 | StatusActive |
| United States | GUDID listing GUDID | Number00850291007109 | Date19 Apr 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- ClotTriever EUDAMEDClotTriever Sheath, 13 Fr GUDID
- Generic Name
- Thrombectomy wire-net introduction set
- Model / Ref / Catalog
- 50-101
- Primary DI / UDI-DI
- 00850291007109
- Basic UDI-DI
- 085029100750-101YZ
- FDA Product Code
- DXE, QEW, KRA, DYB
- EMDN Code
- C0502 Cardiovascular introducer sheaths, valved
- GMDN Term
- Thrombectomy wire-net introduction set
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.5150, 870.1210, 870.1340
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 4.6 MillimeterLength — 15 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000008693
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Inari Medical, Inc.
Properties
Other properties (19)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No